December 4, 2025
DURHAM, NORTH CAROLINA – MED-EL USA announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for MED-EL cochlear implants for children seven months and older with bilateral sensorineural hearing loss (SNHL). This approval makes MED-EL’s cochlear implant system the first and only FDA-approved option for infants this young, enabling earlier access to sound and crucial stages of speech and language development.
“Giving infants the opportunity to hear early in life is critical to maximizing the development of hearing and spoken language. It is extremely gratifying to have led this clinical trial demonstrating the safety and effectiveness of the latest implant technology for children as young as seven months. My hope is this will mean more children will experience the gift of sound soon after birth,” said Nancy M. Young, M.D., Lillian S. Wells Professor of Pediatric Otolaryngology and Medical Director of the Cochlear Implant Program at Ann & Robert H. Lurie Children’s Hospital of Chicago.
The expanded FDA indication also broadens audiologic and speech criteria for children aged 12 months and older, providing the widest pediatric eligibility of any hearing implant manufacturer.
“Many children with significant hearing loss use hearing aids but cannot hear all the sounds essential for understanding spoken language. They must work so much harder than their hearing peers. Expanding the eligibility of these children for cochlear implantation is so important to improving their hearing, language, literacy, and quality of life”
–Nancy M. Young, M.D.
“This is an incredible step forward for families with young children with hearing loss,” said John Sparacio, President and CEO of MED-EL USA. “Giving children access to sound as early as possible can make a world of difference for their future. We are committed to giving every child the best possible start in life through our closest to natural hearing philosophy paired with our advancements in safety and technology.”
Key Data Highlights
- An FDA study in two groups of children found MED-EL cochlear implants to be safe and effective for ages seven to 71 months with bilateral SNHL who do not receive sufficient benefit from hearing aids.
- Among 123 children, 110 showed clinical success within the first year, including 81% in one study group and 88% in the other.
- Major complication rates were low in both groups, and children implanted under 12 months did not experience higher complication rates than older children.
- A post-approval study will collect additional data from children implanted between seven months and 17 years, 11 months who meet the new labeling criteria.
For more information about MED-EL cochlear implants, visit www.medel.com.
About MED-EL
Medical Electronics (MED-EL) is a global leader in implantable hearing solutions, driven by a mission to overcome hearing loss as a barrier to communication and quality of life. Founded in Austria by Ingeborg and Erwin Hochmair—whose early research led to the world’s first micro-electronic multi-channel cochlear implant in 1977—MED-EL has grown to more than 3,000 employees representing around 90 nationalities across 30 locations worldwide.
Today, MED-EL offers the broadest portfolio of implantable and non-implantable hearing solutions, supporting people in 139 countries. Its technologies include cochlear and middle ear implant systems, electric acoustic stimulation systems, and both surgical and non-surgical bone conduction devices. Learn more at www.medel.com.
About Melissa Tumblin
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